Local Quality Specialist

Location: Bulle, Switzerland

Activity rate : 100%

Type of contract: Temporary contract

Start date: ASAP

End date: 31.12.2026

We are looking for an experienced Quality professional to support our local QA activities and ensure strong operational oversight. In these roles, you will review and approve validation documentation?such as risk assessments, protocols, and studies?while contributing to daily QA operations and continuous improvement.

Your key responsibilities:

• Review and approve validation documentation (risk assessments, protocols, studies, CPV reports, project-related deliverables).
• Maintain oversight of product-related documentation and ensure alignment with quality and regulatory expectations.
• Approve deviations, investigations, incidents, and CAPAs, ensuring timely and effective follow-up.
• Support batch record review and batch release/reject activities when needed.
• Provide day-to-day QA support to manufacturing and supply operations in compliance with GxP standards.
• Collaborate with local and global teams to embed and reinforce quality standards.
• Contribute to developing and maintaining a strong on-site quality culture through guidance and proactive engagement.
• Lead or support the Site Change Control Committee to ensure consistent and well-prioritized management of changes.
• Coordinate QA activities related to change control and maintain communication with internal and external stakeholders, including CMOs.
• Identify regulatory assessment needs associated with proposed changes.
• Support quality strategies for assigned projects and contribute to process simplification and continuous improvement initiatives.

What will make you successful:

• Master's degree in Quality, Pharmaceutical Sciences, Biotechnologies, or related field.
• At least 5 years of QA experience in a GMP manufacturing environment.
• Strong background in QA operations, including review of batch records, validation protocols, and risk assessments.
• Experience in biotech preferred; pharmaceutical experience also suitable.
• Ability to work independently, manage multiple priorities, and coordinate complex activities.
• Excellent communication skills in French and English, with strong presentation and stakeholder-management abilities.
• High level of professionalism, discretion, and confidentiality.